Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation

Non-randomized single-arm prospective clinical study.

Study Overview

• Status: Not yet recruiting
• Conditions: Facial Wrinkles; Skin Laxity; Jawline Contour
• Intervention / Treatment: Device: SofWave

Detailed Description

Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shlomit Mann, MSc; Phone Number: +972-4-7800268; Email: Shlomit@sofwave.com
• Study Contact Backup: Name: Ruthie Amir, MD; Phone Number: +972-4-300-3164; Email: ruthie@sofwave.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Dermatology & Laser Surgery Center
      • Principal Investigator: Paul Friedman, MD
      • Contact: Paul Friedman, MD; Phone Number: 713-900-3900; Email: drpaul@dermlasersurgery.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy female and male subjects between the ages 40-55.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
5. Presence of mild to moderate laxity in the lower face and submental area.
6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
7. Able to understand and provide written Informed Consent.
8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
9. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
10. Stable weight over the last 12 weeks and throughout the duration of the study.
11. Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.

12. Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.

    -

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Open wounds or lesions within the intended to treat area.
4. Tattoo or former tattoo at or near treatment area.
5. Presence of active local skin disease that may alter wound healing.
6. Uncontrolled diabetes mellitus.
7. Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
8. Severe solar elastosis.
9. History of smoking in the past 10 years.
10. History of chronic drug or alcohol abuse.
11. Excessive subcutaneous fat on the cheeks.
12. Significant scarring in the area to be treated or history of keloids.
13. Severe or cystic facial acne, and/or Accutane use during the past 6 months.
14. Pacemakers and electronic device implants in the treated area.
15. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
16. Inability to understand the protocol or to provide a signed informed consent.

17. History of cosmetic treatments in the area to be treated including:

    • Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
    • Injectable filler treatments in the past 6 months
    • Injectable neuromodulator treatment in the past 4 months
18. Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
19. Taking anti-platelet or anti-coagulant within the past 2 weeks.
20. Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.

21. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: lax tissue	Device: SofWave; The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation	Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale	12 weeks post treatment follow-up visit
Lower face and upper neck rejuvenation	Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS) at 12 weeks follow-up visit.	12 weeks post treatment follow-up visit

Collaborators and Investigators

• Sponsor: Sofwave Medical LTD

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: facial wrinkles; skin laxity; submental; lower face; upper neck; jawline contour
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Cutis Laxa
• Other Study ID Numbers: SofWave31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No